The present invention relates generally to a method and apparatus for performing multiple quality control (QC) measurements on a pharmaceutical product and, more particularly, to a method and apparatus for performing rapid QC measurements of an on-site or point-of-use prepared pharmaceutical product.
Quality control analysis of pharmaceutical products is an essential task that helps to ensure the safety of products used in the field of health care and eliminate the risk of an out of specification product making its way into a patient. Historically the quality of these pharmaceutical products has been measured by the manufacturer of the product prior to shipment to an end destination. For example, a manufacturer will perform a QC analysis of a parenteral solution after it has been packaged and sealed into a vial/vessel to ensure the quality thereof before shipment to a health care provider. Thus, the pharmaceutical product is considered safe for medical use until its expiration date without any further QC analysis required by the health care provider, assuming proper storage and handling.
With the development of pharmaceutical products whose final preparation occurs immediately prior to injection, QC analysis performed by a manufacturer before shipment of the product is not an option. Thus, to ensure the validity of pharmaceutical products prepared in such a manner, QC analysis must occur on-site where the pharmaceutical product is being prepared for injection into the patient. Such QC analysis must not only be performed accurately and efficiently, but the sterility of the prepared pharmaceutical product must also be ensured.
One example of a pharmaceutical product whose final preparation occurs immediately prior to injection is a hyperpolarized imaging agent (e.g., 13C1-pyruvate) for use in MRI and NMR spectroscopy. Hyperpolarizing of an imaging agent for use in MRI and NMR spectroscopy is done to increase sensitivity in the imaging agent; however, such hyperpolarizing can only be performed immediately prior to injection of the imaging agent into a patient, as the hyperpolarized imaging agent has a very short life span. That is, the imaging agent must be quickly transferred from its production source to its place of intended end use (i.e., injection into a patient) within a matter of minutes. For such a product, QC analysis performed immediately prior to injection is the only option.
The actual QC analysis of the pharmaceutical product can be performed in either a contact or non-contact manner. While a non-contact QC measurement method reduces the chance of contaminants being introduced into the product, such a QC measurement method is not always possible. That is, the existence of applicable methods, cost considerations, and/or the design of a receiver vessel in which the product is located may not allow for non-contact measurement and may necessitate the use of a contact method for performing QC analysis. Regardless of the exact method used, efficacy and safety requirements must be met in performing the QC measurements.
Therefore, a need exists for an apparatus that allows for accurate and efficient QC analysis of a pharmaceutical product whose final preparation occurs just prior to injection into a patient. The apparatus should also allow for both contact and non-contact QC measurements of the pharmaceutical product and meet efficacy and safety requirements regardless of the type of QC analysis performed.